The removal of unwanted and/or life threatening biological material from interior portions of bodily cavities, such as organs, vessels, articular joints and structures, sinuses, and various bodily lumens, is a very common procedure in various medical specialties and disciplines, such as pulmonology, cardiology, urology, gynecology, gastro-enterology, neurology, otolaryngology, orthopedics, and general surgery. Accordingly, various instruments and methods have been employed to perform these procedures, which are generally well known in the art.
One of the most important complications in such procedures is bleeding. The bleeding and resulting morbidity of tissue that occurs in many of the currently known surgical procedures is the result of abrasive, traumatic, and invasive excising and removal techniques. Many of these techniques risk perforation of the vessel or lumen in which the procedure is being performed, resulting in grave complications for the surgeon and patient. In addition, many patient maladies are simply not remedied by these procedures because no interventional, minimally invasive treatment modality exists, the methods are not efficient, safe, and reproducible, and/or the instruments employed lack the appropriate visualization, physiological measurement, and/or feedback necessary to ensure the safety, efficacy, and reproducibility of the procedure. Accordingly, a new type of treatment is required.
One instrument that is commonly used in various types of medical procedures is an inflatable balloon catheter, of which many different types exist, which are utilized to perform various necessary functions. For example, these inflatable balloons are often used to control or stop bleeding, to hold instruments in place, or to prevent or facilitate other flow or movement within the bodily cavity. For example, many urological catheters are held in place via a balloon that impacts the sidewalls of the urinary tract, many gynecological instruments are held in place via balloons that impact the sidewalls of the vaginal vault, endovascular balloons are often used to control bleeding, inflatable balloons are sometimes used to control the backflow of radio-opaque agents injected into the cystic duct to detect the presence of gall stones during general surgical cholecystectomy procedures, and, recently, balloon catheters have been employed to release sinus congestion.
One particular application of such catheters is lung cancer. Among all types of cancer, this has the lowest survival rate, as more than one third of all deaths due to cancer are caused by lung cancer. Over 1.5 million new cases are diagnosed worldwide each year. The most frequent cause of death for lung cancer patients is airway obstruction. In lung cancer patients, one third of all cases initially, and another third of the cases in the long term, present main airway obstruction, which may cause asphyxia, hemorrhaging, and infection. These complications are the most frequent causes of death in lung cancer patients.
Use of interventional bronchoscopy for the treatment of lung cancer and the resultant airway obstruction increases the quality of life and survival rates of patients suffering from Chronic Obstructive Pulmonary Disease (COPD) and the obstructive co-morbidities associated with the cancer. Accordingly, balloon catheters have been routinely used with various endoscopes and with flexible and rigid bronchoscopes for dilation, as a tamponade to stop bleeding, and as an interference fixation device to hold instruments in place and prevent the retropulsion of those instruments under backflow pressure.
In light of the aforementioned need for a new type of treatment for removing undesirable biological material in bodily cavities, it has been realized that inflatable balloon catheters may further be employed as interventional tools for the excision and removal of such materials—such as endoluminal obstructions and tumors and endovascular occlusions—in various applications, such as the aforementioned interventional medical specialties of pulmonology, cardiology, urology, gynecology, gastro-enterology, neurology, otolaryngology, and general surgery. The use of balloon catheters in this way has presented a method of treatment that is simple, safe, highly effective, and inexpensive compared to other types of methods and devices that are used, such as mechanical, laser, electrocautery, cryotherapy, etc.
Accordingly, a new class of balloons has been suggested for this purpose, such as that disclosed in U.S. Pat. No. 8,226,601 to Gunday et al., the specification of which is hereby incorporated by reference herein in its entirety. This device employs a balloon catheter with an inflatable resector balloon. Using this device, one is able to treat obstruction in a bodily cavity by inserting the catheter with the balloon deflated into the bodily cavity. The balloon is aligned with the obstruction and then repeatedly inflated and deflated in pulsed fashion. The balloon's abrasive surface, when gradually pulsed in this way, gradually and non-traumatically resects the obstruction, while causing minimal damage to the surrounding, healthy tissue.
In order to accomplish this, the device must be inserted into a narrow and vital body cavity, such as a respiratory airway or coronary artery, and the doctor must conduct a precise procedure using the inserted device. Accordingly, it is desirable to have imaging available to provide the doctors with a view that facilitates precise positioning and operation of the device. Additionally, fluid must be continually supplied and withdrawn from resecting balloon in order for it to function. It is also desirable to deliver diagnostic and/or therapeutic agents to the target site to help diagnose and treat the pathology.
All of these features, of course, add to the complexity of the resection system. In order to accommodate them, the catheter must have multiple lumens. Furthermore, the catheter must remain as slim as possible to be able to enter narrow passages in the body. Finally, all of these devices and components (i.e., optics, pressurized fluid for the balloon, drugs) must be fed into the various lumens of the catheter from outside of the patient's body.
What is desired, therefore, is a resector balloon catheter for removing undesirable biological materials that is able to facilitate precise positioning an operation of the device. What is also desired is a resector balloon catheter that is able to facilitate diagnosis and/or additional treatment steps during the resection procedure. What is further desired is an assembly that provides balloon resection in a slim catheter.